Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.

January 22, 2018 updated by: Göteborg University
The study investigates effects related to muscle protein metabolism at provision of Total Parenteral nutrition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized study investigating alterations in muscle protein metabolism at provision of parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate factors related to activation of skeletal muscle protein synthesis. Patients scheduled for major gastrointestinal surgery are included. Muscle specimens are collected during surgery.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, SE 41345
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major gastrointestinal surgery
  • Assumed need of post-operative artificial nutrition.

Exclusion Criteria:

  • Insulin dependent diabetes
  • Steroid medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Total Parenteral Nutrition (TPN)
Overnight infusion of Parenteral Nutrition supplied in all-in one bag -format. Infusion-rate of 0.16 gram Nitrogen/kg/day.
Drug: TPN
Other Names:
  • TPN infusion
PLACEBO_COMPARATOR: Control (saline infusion)
Overnight infusion of physiological saline at the same infusion-rate; ml/kg as intervention (TPN).
Other: Control
Other Names:
  • Physiological saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle protein metabolism
Time Frame: Single evaluation point at 12-14 hours following the start of overnight infusion.
Alterations in muscle protein metabolism will be assessed by various standard techniques for gene and protein expression. Combined measurements of cell-signaling molecules representing anabolic and catabolic signaling pathways will be evaluated in relation to transcription of muscle myosin proteins.
Single evaluation point at 12-14 hours following the start of overnight infusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Kent Lundholm, Department of Surgery, University of Gothenburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2005

Primary Completion (ACTUAL)

December 31, 2014

Study Completion (ACTUAL)

December 31, 2014

Study Registration Dates

First Submitted

December 21, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (ACTUAL)

January 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB1+2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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